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Weight Management in Mothers and Adult Daughters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787902
Recruitment Status : Suspended (Trial suspended due to COVID-19.)
First Posted : June 1, 2016
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Becky Marquez, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE February 22, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2016)
Weight change [ Time Frame: 16 weeks ]
Change in weight from baseline to post-intervention (16 weeks).
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
Weight change [ Time Frame: 16 weeks ]
Change in weight from baseline to post-intervention.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • Anthropometrics [ Time Frame: baseline and post-intervention (16 weeks) ]
  • Blood pressure [ Time Frame: baseline and post-intervention (16 weeks) ]
  • Communication [ Time Frame: baseline and post-intervention (16 weeks) ]
  • Relationship factors (dyad, family, social networks) [ Time Frame: baseline and post-intervention (16 weeks) ]
  • Psychosocial factors [ Time Frame: baseline and post-intervention (16 weeks) ]
  • Eating behavior [ Time Frame: baseline and post-intervention (16 weeks) ]
  • Physical activity [ Time Frame: baseline and post-intervention (16 weeks) ]
  • Weight control behavior [ Time Frame: baseline and post-intervention (16 weeks) ]
  • Treatment attendance and adherence [ Time Frame: between baseline and post-intervention (16 weeks) ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weight Management in Mothers and Adult Daughters
Official Title  ICMJE Improving Communication and Collaboration for Weight Management in Mother-daughter
Brief Summary

The purpose of this study is to develop, implement, and evaluate a behavioral weight management intervention with a communication training component for Mexican-American women. The study has three specific aims.

Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral weight loss treatment using results from formative data collected from Mexican-American mother-daughter dyads. The adapted intervention will focus on improving dyadic communication and collaboration for providing reciprocal support for healthy eating and physical activity behaviors.

Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter dyads. Dyads will be randomly assigned to partner-based treatment with or without communication skills training.

Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and psychosocial variables with changes in measures assessing interpersonal communication.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overweight or Obese
Intervention  ICMJE
  • Behavioral: Communication
    Behavioral weight management program adapted for mother-daughter dyads with communication skills training
  • Behavioral: Standard
    Behavioral weight management program adapted for mother-daughter dyads without communication skills training
Study Arms  ICMJE
  • Experimental: Communication
    Behavioral weight loss program with communication skills training
    Intervention: Behavioral: Communication
  • Active Comparator: Standard
    Standard behavioral weight loss program
    Intervention: Behavioral: Standard
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 26, 2016)
168
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female
  • Body mass index of 25-50 kg/m2
  • Mexican or Mexican-American

Exclusion Criteria:

  • Pregnancy or plans to become pregnant in the next year
  • 5% weight loss in the last 3 months
  • History of bariatric surgery
  • Serious medical condition or psychological disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787902
Other Study ID Numbers  ICMJE 151345
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Becky Marquez, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Diego
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP